Informations générales (source: ClinicalTrials.gov)

NCT06136403 En recrutement
A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses (GENEPID)
Interventional
  • Épidermolyse bulleuse
  • Ichtyose
  • Maladies génétiques de la peau
  • Épidermolyse bulleuse simple
  • Érythrodermie ichtyosiforme congénitale
  • Ichtyose lamellaire
Phase 2
Centre Hospitalier Universitaire de Nice (Voir sur ClinicalTrials)
mars 2023
octobre 2026
24 mai 2025
The goal of this clinical trial is to learn about deucravacitinib treatment in adults with inflammatory epidermal genodermatoses . The main question it aims to answer are: describe efficacity and safety of this treatment. Participants will take treatments and have to use bullets during the study period.
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Etablissements

Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de Nice - 06003 - Nice - Chu de Nice - France En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Subject has congenital skin fragility with skin and/or mucosal blisters, a clinical
phenotype of EBS-sev and a laboratory confirmed diagnosis of EBS by KRT5 and/or 14
mutation (autosomal only) OR a clinical phenotype of inflammatory ichthyosis (IC)
including keratinopathic ichthyosis due to KRT1/10 mutation, ECI with identified
genetic mutations (TGM5, NIPAL4, ABCA12, etc...).

- Subject has at least a mean daily number of 4 new blisters (EBS-sev) OR an ISS >
50/128.

- Subject agrees not to use any topical therapies other than the investigator
approved.


- Subjects with another form of ICI ie Netherton syndrome, Kid syndrome etc.

- Infectious/Immune-related Exclusions

- Medical History and Concurrent Diseases